The Effects of Nicotine Chewing Gum in Parkinson's Disease (PD)

New York Institute of Technology

Status: Completed

Conditions: Low Blood Pressure; Parkinsons Disease

Treatments: Dietary Supplement: Nicotine gum

Study type: Interventional

Funder types: Other

Identifiers

NCT02452125

BHS-1118

Details and patient eligibility

About

The objective of this experiment is:

To determine if nicotine chewing gum will improve acute episodes of orthostatic hypotension in PD subjects.

Full description

Subjects will be asked to sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes.

After all inclusion criteria has been met, subjects will then wear an automated BP cuff and be administered 4mg of nicotine gum (Nicorette™). They will be instructed to use it according to manufacturer's directions and remain chewing the gum for 30 minutes. The subject will remain in a seated position and BP and HR will be recorded every 5 minutes for 30 minutes. After 30 minutes the gum will be removed and subjects will still have HR and BP monitored in the seated position for another hour every 10 minutes. All values will be compared to pretreatment values. After 120 minutes if the subject is non-symptomatic, they can go home.

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• a diagnosis of PD
• a diastolic BP less than 90 mmHg
• and/or a systolic BP lower than 100mHg.

Exclusion criteria

• current tobacco users in all forms of tobacco
• severe dysphasia (difficulty swallowing)
• previous tobacco users who might be at risk for re-addiction.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Nicotine Gum

Experimental group

Description:

Nicotine chewing gum administered for 30 minutes

Treatment:

Dietary Supplement: Nicotine gum